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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Type  Injury  
Event Description

It was initially reported by the physician's office that a pt mentioned that it seems that her pulse rate seems to drop at night. It was unk if this was occurring with stimulation. The pt was going to be referred for further evaluation on the issue. No further details have been made available on the issue. Good faith attempts to obtain additional info on the issue have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1671547
Report Number1644487-2010-01035
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number103
Device LOT Number2318
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/30/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/29/2010 Patient Sequence Number: 1
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